Novartis Tasigna (nilotinib) 300mg twice daily has obtained approval for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase from the Swiss health authority Swissmedic.
Tasigna is the new therapeutic option for newly diagnosed patients since the launch of Glivec (imatinib), providing an advance for patients with this blood cancer.
Tasigna has been approved after it has been designated for a fast track review by Swissmedic, which resulted from the positive results of a 12 months pivotal Phase III trial, ENESTnd, demonstrating superiority to the standard of care Glivec in achieving molecular and cytogenetic response and delaying cancer progression.
Tasigna has received the first-line indication approval from the US Food and Drug Administration in June.
Novartis Oncology president Herve Hoppenot said that Switzerland was the first country to approve Tasigna in 2007 for its original indication as a second-line treatment after Glivec.
"Now, with this approval of Tasigna as a first-line treatment, we are pleased to offer newly diagnosed CML patients a new and even more effective option for delaying disease progression," Hoppenot said.